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| https://www.youtube.com/@mantrasystems | Watch us onYouTube |
| https://g.page/mantrasystems | Consult House, 4 Hayland Street, Sheffield, S9 1BY, UK |
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<h1>Enabling <span>Global Medical Device</span> Market Access</h1>
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<span>Delivering collaborative & personalised</span>
<span>medical device consulting experiences</span>
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<a href="#enquiry" class="button big full-mobile">Let's talk</a>
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<h2 class="hide-screen">Our Clients say</h2>
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<blockquote>
<div class="quote size-medium">
<p>Mantra Systems have provided outstanding quality literature search reports and State of the Art appraisals for our medical devices; <b><span class="inline-desktop">I would</span> thoroughly recommend them.</b></p>
</div>
<div class="source">
<span class="initials ">TD</span>
<p>
<span>Dr. Trevor Day</span>
<span>Principal Scientist</span>
<strong>Procter & Gamble</strong>
</p>
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</blockquote>
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<blockquote>
<div class="quote size-small">
<p>Mantra Systems' expertise, attention to detail towards appropriate literature papers, and dedication to accuracy have truly made a difference. Their commitment to delivering high-quality work is evident and I look forward to the possibility of working together again in the future.</p>
</div>
<div class="source">
<span class="initials ">A</span>
<p>
<span>Ambal</span>
<span>Engineering Quality & Regulatory Manager</span>
<strong>LifeSignals</strong>
</p>
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<h2 class="h1">Our Clients</h2>
<p class="lead align-middle col-7">We serve an international client-base covering all classes of medical device across a wide range of clinical fields.</p>
<figure class="world-map spacer-up spacer-down">
<img src="/assets/images/content/other/client-world-map.png" width="2292" height="1082" alt="A world map showing the flags of our clients from the UK, Europe, USA, Central America, Asia and the Middle East" loading="lazy">
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<p class="lead align-middle col-9">Our clients are based around the world, hailing from the UK, Europe, North America, Central America, Asia and the Middle East, and vary in size from pre-market start-ups to stockmarket-listed multinationals.</p>
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<li class="col col-4">
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<strong>310<span>+</span></strong>
<span>
<span>Satisfied</span>
<span>Clients</span>
</span>
</div>
</li>
<li class="col col-4">
<div class="content">
<strong>77<span>%</span></strong>
<span>
<span>Return</span>
<span>Customers</span>
</span>
</div>
</li>
<li class="col col-4">
<div class="content">
<strong>100<span>%</span></strong>
<span>
<span>Notified Body</span>
<span>Approval</span>
</span>
</div>
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</ul>
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<div class="strip section bg-4" id="services">
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<h2 class="h1 align-center"><span>Medical Device</span> Market Access Consulting</h2>
<p class="lead align-center align-middle col-9">Expand your business potential with forward-thinking medical device market access strategies</p>
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<a href="/medical-device-regulatory-consulting-services/mdr-consulting" class="content">
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<p>Achieve MDR approval with confidence</p>
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<li>
<a href="/medical-device-regulatory-consulting-services/ivdr-consulting" class="content">
<h3>IVDR Consulting</h3>
<p>Get market access for your IVD devices</p>
</a>
</li>
<li>
<a href="/medical-device-market-access-consulting/heor-value-communication" class="content">
<h3>HEOR & Value Communication</h3>
<p>Drive your medical device market share</p>
</a>
</li>
<li>
<a href="/medical-device-market-access-consulting/preclinical-testing" class="content">
<h3>Preclinical Testing</h3>
<p>Medical device validation & verification</p>
</a>
</li>
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<h2 class="h1 align-center"><span>Resources for</span> <span>Medical Device Regulation</span></h2>
<p class="lead lead align-center align-middle col-9">Get guidance on medical device regulation through exclusive resources written by our subject matter experts</p>
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<a href="/eu-mdr-compliance/" class="content">
<h3>EU MDR Compliance Guide</h3>
<p>A free Medical Device Regulation guide</p>
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<h3>MDR & MDCG Chatbot</h3>
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<h3>Online Training Courses</h3>
<p>Drive your own regulatory strategy</p>
</a>
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<a href="/enable-ce-mark/technical-document-templates/" class="content">
<h3>Document Templates</h3>
<p>Build your medical device technical file</p>
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<a href="/articles/" class="content">
<h3>Articles & News</h3>
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<h2 class="hide-screen">Our Clients say</h2>
<ul class="row">
<li class="col col-6">
<blockquote>
<div class="quote size-medium">
<p>Mantra Systems authored an excellent and thorough Clinical Evaluation Report (CER) for our medical device, according to both UK & EU MDR, which was delivered on time. I was highly impressed by their expertise and professionalism throughout and wouldn't hesitate to work with them again.</p>
</div>
<div class="source">
<span class="initials ">MH</span>
<p>
<span>Monica Hodgkinson</span>
<span>Regulatory Compliance Manager</span>
<strong>GV Health Ltd</strong>
</p>
</div>
</blockquote>
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<div class="quote size-small">
<p>Not only was Mantra Systems very easy to work with, but their clinical knowledge and dedication to helping us meet the tight timelines for response was top notch. We have worked with other consultants in the past, but we were never satisfied with the output. Other companies required us to put in a lot of extra labor to format and sometimes redo what was provided – that is not the case with Mantra Systems. We hope to have another opportunity to work with them.</p>
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<div class="source">
<span class="initials ">CC</span>
<p>
<span>Courtney Civik</span>
<span>Regulatory Affairs Manager</span>
<strong>Northgate Technologies Inc.</strong>
</p>
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<h3>Mantra Systems at MEDICA 2024</h3>
<p>Mantra Systems is going to MEDICA 2024, the largest medical trade fair in the world. We hope to see you there.</p>
<div class="meta">
<img src="/assets/images/content/team/richard-jones.jpg" alt="Richard Jones" class="author" loading="lazy">
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<b>Richard Jones</b>
<span>Operations Director</span>
</span>
</div>
</div>
</a>
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<a href="/articles/regulation-EU-2024-1860-its-impact-on-eu-mdr-and-ivdr">
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</figure>
<div class="text">
<h3>Regulation (EU) 2024/1860 - Its impact on EU MDR and IVDR</h3>
<p>How does the recent Regulation (EU) 2024/1860 amendment affect the EU MDR & IVDR?</p>
<div class="meta">
<img src="/assets/images/content/team/shona-richardson.jpg" alt="Shona Richardson" class="author" loading="lazy">
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<b>Shona Richardson</b>
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<h3>MDCG 2024-10 - Orphan medical devices</h3>
<p>How to apply MDR pre-market clinical evidence requirements to medical devices intended for limited usage.</p>
<div class="meta">
<img src="/assets/images/content/team/simon-cumiskey.jpg" alt="Dr Simon Cumiskey" class="author" loading="lazy">
<span>
<b>Dr Simon Cumiskey</b>
<span>Senior Lead Medical Writer</span>
</span>
</div>
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<div class="text">
<h3>A medical device's intended purpose - what is the point?</h3>
<p>How do you define intended purpose, indication for use, intended clinical benefits, and claims?</p>
<div class="meta">
<img src="/assets/images/content/team/simon-cumiskey.jpg" alt="Dr Simon Cumiskey" class="author" loading="lazy">
<span>
<b>Dr Simon Cumiskey</b>
<span>Senior Lead Medical Writer</span>
</span>
</div>
</div>
</a>
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<div class="text">
<h3>EnableChat - Your AI-powered MDR and MDCG chatbot</h3>
<p>Search the MDR and MDCG documents in seconds by asking EnableChat your questions.</p>
<div class="meta">
<img src="/assets/images/content/team/simon-cumiskey.jpg" alt="Dr Simon Cumiskey" class="author" loading="lazy">
<span>
<b>Dr Simon Cumiskey</b>
<span>Senior Lead Medical Writer</span>
</span>
</div>
</div>
</a>
</li>
<li class="col col-4">
<a href="/articles/staying-vigilant-a-guide-to-searching-for-adverse-events-data">
<figure>
<img src="/assets/images/content/articles/staying-vigilant-a-guide-to-searching-for-adverse-events-data.jpg" alt="Searching adverse event databases for vigilance data" width="660" height="371" loading="lazy">
</figure>
<div class="text">
<h3>Staying vigilant - A guide to searching for adverse events data</h3>
<p>We discuss the pros and cons of existing adverse event databases for vigilance data searching.</p>
<div class="meta">
<img src="/assets/images/content/team/simon-cumiskey.jpg" alt="Dr Simon Cumiskey" class="author" loading="lazy">
<span>
<b>Dr Simon Cumiskey</b>
<span>Senior Lead Medical Writer</span>
</span>
</div>
</div>
</a>
</li>
</ol>
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<h2>Do you need support with your medical device approval strategy?</h2>
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<a href="#enquiry" class="button">Enquire today</a>
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